Cleared Traditional

LEESPEC DISPOSABLE VAGINAL SPECULUM

K021017 · Itl Corporation Pty, Ltd. · Obstetrics & Gynecology

Jun 2002

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K021017 is an FDA 510(k) clearance for the LEESPEC DISPOSABLE VAGINAL SPECULUM, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Itl Corporation Pty, Ltd. (Fyshwick, Canberra Act, AU). The FDA issued a Cleared decision on June 19, 2002, 82 days after receiving the submission on March 29, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K021017 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2002
Decision Date	June 19, 2002
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF